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Submission of Food and Drug Administration Import Data in the Automated Commercial Environment (in English)
The Law Library
Synopsis "Submission of Food and Drug Administration Import Data in the Automated Commercial Environment (in English)"
Submission of Food and Drug Administration Import Data in the Automated Commercial Environment (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library presents the complete text of the Submission of Food and Drug Administration Import Data in the Automated Commercial Environment (US Food and Drug Administration Regulation) (FDA) (2018 Edition). Updated as of May 29, 2018 The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule/regulation to establish requirements for the electronic filing of entries of FDA-regulated products in the Automated Commercial Environment (ACE) or any other electronic data interchange (EDI) system authorized by the U.S. Customs and Border Protection Agency (CBP), in order for the filing to be processed by CBP and to help FDA in determining admissibility of that product. ACE is a commercial trade processing system operated by CBP that is designed to implement the International Trade Data System (ITDS), automate import and export processing, enhance border security, and foster U.S. economic security through lawful international trade and policy. FDA is a Partner Government Agency (PGA) for purposes of submission of import data in ACE. As of July 23, 2016, ACE became the sole EDI system authorized by CBP for entry of FDA-regulated articles into the United States. We also updated certain sections of FDA regulations related to imports. This rule will facilitate effective and efficient admissibility review by the Agency and protect public health by allowing FDA to focus its limited resources on those FDA-regulated products being imported or offered for import that may be associated with a greater public health risk. This book contains: - The complete text of the Submission of Food and Drug Administration Import Data in the Automated Commercial Environment (US Food and Drug Administration Regulation) (FDA) (2018 Edition) - A table of contents with the page number of each section
